S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
Conditions
Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
ESCC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S1 combined with cisplatin
Type: Drug
Overall Status
Recruiting
Summary
Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria

- Joined the study voluntarily and signed informed consent form;

- Age 18-75

.Presence of at least one index lesion measurable by CT scan or MRI

- recurrence/metastasis of Esophageal carcinoma or gastroesophageal cancer confirmed by pathology

- No radiotherapy, chemotherapy or other treatments prior to enrollment

- PS ECOG 0-1

- Life expectancy of more than 3 months

- ANC≥2×109/L,PLT≥100×109/L,Hb≥90g/L

- Cr≤1.0×UNL

- TBIL≤1.25×UNL; ALT/AST≤2.5×UNL,with hepatic metastases ALT/AST≤5.0×UNL;AKP≤2.5×UNL

Exclusion Criteria:

- there is radical cure of the cancer

- uncontrolled chronic diarrhea and esophageal obstruction

- Neurological or mental abnormalities Influence of cognitive ability include central nervous system metastases

- Severe complication(s), e.g.,uncontrolled active infection,myocardial infarction,hypertension,arrhythmia,stenocardia

- Patient who has metastasis except cured skin basal cell carcinoma and carcinoma in situ of cervix

- accept other antitumor therapy •Female patients during their pregnant and lactation period, or patients without contraception
Location
Cancer hospital Fudan University
Shanghai, Shanghai, China
Status: Recruiting
Contact: Chang jian hua, MD,PHD - 64175590 - changjianhua@163.com
Start Date
November 2011
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page